Itay Abuhav

ISO 13485:2016 (eBook, ePUB)

A Complete Guide to Quality Management in the Medical Device Industry, Second Edition

• Format: ePub

Produktbeschreibung

This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality management system; change in the documentation for quality managemeent systems and finally, present the different methods of implementation of the standard requirements within the organization.This new version was initiated in 2016, thus all apprpriate enterprises using the old standard must convert to the new version, now available.The Second Edition will clarify, explain and demonstrate the new version.

---

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, HR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.

Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 892
• Erscheinungstermin: 11. Mai 2018
• Englisch
• ISBN-13: 9781351000772
• Artikelnr.: 54033230

Autorenporträt

Itay Abuhav has been acting as a consultant for many organizations in various areas for the past 15 years, specializing in the quality management/control industry, consulting with a number of small- to medium-sized firms dealing with implementing quality management systems, with a major focus on the European medical device industry. He is highly qualified to certify organizations to various standards: ISO 9001 and ISO 13485. The author has two active websites related to these topics, namely, www.9001quality.com and www.13485quality.com.